Obstructive Sleep ApneaNCT01173406
Education Programme on Continuous Positive Airway Pressure Treatment
A study testing CPAP education in people with Obstructive Sleep Apnea, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or over.
- Newly diagnosed of OSA and will be starting CPAP therapy
Who cannot join
- Not suitable for CPAP therapy
- Previously received CPAP therapy
- Possesses restrictive and obstructive pulmonary diseases
- Possesses hypoventilation
- Under unstable health conditions
- pregnant
- History of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial
The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.
Read the detailed description
Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP education
- Keywords
- Continuous Positive Airway Pressure treatment, Adherence, Education
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP educationBehavioural
Standard CPAP education plus an session and one telephone follow up
| Study group | Role | What they receive |
|---|---|---|
| Standard care (SC) | Sham comparator | Standard care Receives: Behavioral: CPAP education |
| Extended education (ME+SC) | Active comparator | Motivational enhancement education + Standard care Receives: Behavioral: CPAP education |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP usage
To examine the efficacy of an education programme in enhancing the adherence of using CPAP.
Measured: 12-week
Secondary outcomes (1)
Daytime Sleepiness
To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Yuen Kwan Agnes, The University of Hong Kong
- Investigators
- Agnes YK Lai, MSc, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173406
- Sponsor's protocol ID
- HKCTC-1113
- Status last verified
- Oct 2013
- First submitted
- 27 Jul 2010
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.
PubMed 24810282Lai AY, Fong DY, Lam JC, Weaver TE, Ip MS. Linguistic and psychometric validation of the Chinese version of the self-efficacy measures for sleep apnea questionnaire. Sleep Med. 2013 Nov;14(11):1192-8. doi: 10.1016/j.sleep.2013.04.023. Epub 2013 Sep 16.
PubMed 24051110
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01173406
- Acronym / sponsor ID
- HKCTC-1113
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Continuous Positive Airway Pressure treatment, Adherence, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.
Detailed description
Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care (SC) | Sham comparator | Behavioral: CPAP educationStandard care |
| Extended education (ME+SC) | Active comparator | Behavioral: CPAP educationMotivational enhancement education + Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or over.
- Newly diagnosed of OSA and will be starting CPAP therapy
Key exclusion criteria (7 listed)
- Not suitable for CPAP therapy
- Previously received CPAP therapy
- Possesses restrictive and obstructive pulmonary diseases
- Possesses hypoventilation
- Under unstable health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP educationStandard CPAP education plus an session and one telephone follow up | Behavioural | Extended education (ME+SC), Standard care (SC) |
Primary outcome
CPAP usage
Time frame: 12-week
To examine the efficacy of an education programme in enhancing the adherence of using CPAP.
1 secondary outcome
Daytime Sleepiness
Time frame: 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
- Derived from this study: PubMed 24810282Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.
- Derived from this study: PubMed 24051110Lai AY, Fong DY, Lam JC, Weaver TE, Ip MS. Linguistic and psychometric validation of the Chinese version of the self-efficacy measures for sleep apnea questionnaire. Sleep Med. 2013 Nov;14(11):1192-8. doi: 10.1016/j.sleep.2013.04.023. Epub 2013 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes YK Lai, MSc principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP education in people with Obstructive Sleep Apnea, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP usage (time frame: 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01173406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.